Cancer-related Cognitive DysfunctionNCT06870539
Feasibility of Saliva and Remote Monitoring of Active Cytomegalovirus (CMV) Infection and Symptoms During Ovarian Cancer Treatment
An observational study of Cancer-related Cognitive Dysfunction and Cytomegaloviral Infection, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer-related Cognitive Dysfunction, Cytomegaloviral Infection, Fallopian Tube Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ovarian cancer undergoing active treatment at the Mayo Clinic
Who may be able to join
- Age ≥ 18
- Ability to read and write in English
- Diagnosed with ovarian cancer (ovarian, primary peritoneal, fallopian tube)
- Receiving care from providers at Mayo Clinic
- Regardless of diseases status, actively receiving treatment for ovarian cancer (frontline, maintenance, progression, recurrence)
Who cannot join
- Pregnant at the time of study participation
- Inability to provide informed written consent
- History of dementia, stroke, brain tumors or other condition which may impair cognitive functioning
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer.
- Conditions
- Cancer-related Cognitive Dysfunction, Cytomegaloviral Infection, Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Cytomegalovirus Infections, Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo saliva sample collection as well as in-clinic or at-home blood sample collection on study. Patients also complete questionnaires, undergo cognitive function testing, and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using saliva and blood samples to remotely monitor cytomegalovirus (CMV) infection
Assessed through collection and comparison of blood and saliva samples collected from individuals receiving treatment for ovarian cancer. Samples may be collected in clinic or at home following study enrollment. Saliva will be self-collected using Oragene OGR-600 kits. Blood samples will be collected at the time of another scheduled clinic blood draw (Aim 1) or at home through a home phlebotomy service (Aim 2).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start7 Mar 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amanika Kumar, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870539
- Sponsor's protocol ID
- 24-011332
- Other IDs
- NCI-2025-01230, 24-011332, P50CA136393
- Status last verified
- Sep 2025
- First submitted
- 6 Mar 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Saliva and Remote Monitoring of Active Cytomegalovirus (CMV) Infection and Symptoms During Ovarian Cancer Treatment
- ClinicalTrials.gov ID
- NCT06870539
- Acronym / sponsor ID
- 24-011332
- Conditions
- Cancer-related Cognitive Dysfunction, Cytomegaloviral Infection, Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo saliva sample collection as well as in-clinic or at-home blood sample collection on study. Patients also complete questionnaires, undergo cognitive function testing, and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian cancer undergoing active treatment at the Mayo Clinic
Key inclusion criteria (5 listed)
- Age ≥ 18
- Ability to read and write in English
- Diagnosed with ovarian cancer (ovarian, primary peritoneal, fallopian tube)
- Receiving care from providers at Mayo Clinic
- Regardless of diseases status, actively receiving treatment for ovarian cancer (frontline, maintenance, progression, recurrence)
Key exclusion criteria (3 listed)
- Pregnant at the time of study participation
- Inability to provide informed written consent
- History of dementia, stroke, brain tumors or other condition which may impair cognitive functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational |
Primary outcome
Using saliva and blood samples to remotely monitor cytomegalovirus (CMV) infection
Time frame: Baseline
Assessed through collection and comparison of blood and saliva samples collected from individuals receiving treatment for ovarian cancer. Samples may be collected in clinic or at home following study enrollment. Saliva will be self-collected using Oragene OGR-600 kits. Blood samples will be collected at the time of another scheduled clinic blood draw (Aim 1) or at home through a home phlebotomy service (Aim 2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- University of Minnesota Medical School Clinical Trials \& StudiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanika Kumar, MD principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Cognitive Dysfunction and Cytomegaloviral Infection, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using saliva and blood samples to remotely monitor cytomegalovirus (CMV) infection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.